510(k) K083121
- Device
- NEO MAPCATH SENSOR STYLET
- Applicant
- CORPAK MEDSYSTEMS
- 510(k) number
- K083121
- Product code
- OMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-11
- Date received
- 2008-10-22
- Regulation
- 880.5970
- Classification name
- Percutaneous, Implanted, Long-term Intravascular Catheter Accessory For Catheter Position
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHANIE WASIELEWSKI
- Address
- 100 Chaddick Dr. Wheeling IL US 60090 60090
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093510 | LUMENVU CATHETER GUIDANCE SYSTEM | Sonosite,Inc. | 2010-08-23 |
Legacy Summary#
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FDA Review#
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